NA 216.055Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982155221), received between Jan 3, 2018 and Jan 3, 2018 — classified as 3 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HARDWARE REMOVAL AND REVISION SURGERY PERFORMED ON (B)(6) 2017, DUE TO NON-UNION. THE PATIENT ORIGINALLY HAD AN ANKLE FUSION PERFORMED ON AN UNKNOWN DATE AND WAS IMPLANTED WITH ONE (1) 6.5 MM CANCELLOUS BONE SCREW 16 MM THREAD FOR 45 MM, TWO (2) CANCELLOUS BONE SCREWS 16 MM THREAD FOR 50 MM, THREE (3) CANCELLOUS BONE SCREWS 16 MM THREAD FOR 55 MM AND ONE (1) CANNULATED CANCELLOUS SCREW 16 MM THREAD 65 MM. ON (B)(6) 2017, THE PATIENT WAS DISCOVERED TO HAVE A NON-UNION AND ALL THE ORIGINALLY IMPLANTED CONSTRUCTS WERE REMOVED FULLY INTACT. THE PATIENT WAS REVISED TO TWO (2) ONE-THIRD TUBULAR PLATES AND THREE (3) CORTEX SCREWS. THE PROCEDURE WAS COMPLETED UNEVENTFULLY WITH NO SURGICAL DELAY. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED TO COMPLETE THE PROCEDURE AND THE PATIENT WAS DOING WELL POST-OPERATIVELY. (B)(4).

  Patient problems: Impaired Healing; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7160956 ↗
• InjuryJan 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HARDWARE REMOVAL AND REVISION SURGERY PERFORMED ON (B)(6) 2017, DUE TO NON-UNION. THE PATIENT ORIGINALLY HAD AN ANKLE FUSION PERFORMED ON AN UNKNOWN DATE AND WAS IMPLANTED WITH ONE (1) 6.5 MM CANCELLOUS BONE SCREW 16 MM THREAD FOR 45 MM, TWO (2) CANCELLOUS BONE SCREWS 16 MM THREAD FOR 50 MM, THREE (3) CANCELLOUS BONE SCREWS 16 MM THREAD FOR 55 MM AND ONE (1) CANNULATED CANCELLOUS SCREW 16 MM THREAD 65 MM. ON (B)(6) 2017, THE PATIENT WAS DISCOVERED TO HAVE A NON-UNION AND ALL THE ORIGINALLY IMPLANTED CONSTRUCTS WERE REMOVED FULLY INTACT. THE PATIENT WAS REVISED TO TWO (2) ONE-THIRD TUBULAR PLATES AND THREE (3) CORTEX SCREWS. THE PROCEDURE WAS COMPLETED UNEVENTFULLY WITH NO SURGICAL DELAY. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED TO COMPLETE THE PROCEDURE AND THE PATIENT WAS DOING WELL POST-OPERATIVELY. (B)(4).

  Patient problems: Impaired Healing; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7160890 ↗
• InjuryJan 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HARDWARE REMOVAL AND REVISION SURGERY PERFORMED ON (B)(6) 2017, DUE TO NON-UNION. THE PATIENT ORIGINALLY HAD AN ANKLE FUSION PERFORMED ON AN UNKNOWN DATE AND WAS IMPLANTED WITH ONE (1) 6.5 MM CANCELLOUS BONE SCREW 16 MM THREAD FOR 45 MM, TWO (2) CANCELLOUS BONE SCREWS 16 MM THREAD FOR 50 MM, THREE (3) CANCELLOUS BONE SCREWS 16 MM THREAD FOR 55 MM AND ONE (1) CANNULATED CANCELLOUS SCREW 16 MM THREAD 65 MM. ON (B)(6) 2017, THE PATIENT WAS DISCOVERED TO HAVE A NON-UNION AND ALL THE ORIGINALLY IMPLANTED CONSTRUCTS WERE REMOVED FULLY INTACT. THE PATIENT WAS REVISED TO TWO (2) ONE-THIRD TUBULAR PLATES AND THREE (3) CORTEX SCREWS. THE PROCEDURE WAS COMPLETED UNEVENTFULLY WITH NO SURGICAL DELAY. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED TO COMPLETE THE PROCEDURE AND THE PATIENT WAS DOING WELL POST-OPERATIVELY. THIS IS REPORT 3 OF 7 FOR (B)(4).

  Patient problems: Impaired Healing; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7160567 ↗